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Frontier Pharma: Pancreatic Cancer-Identifying and Commercializing First-in-Class Innovation

Frontier Pharma: Pancreatic Cancer-Identifying and Commercializing First-in-Class Innovation


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Executive Summary

Frontier Pharma: Pancreatic Cancer-Identifying and Commercializing First-in-Class Innovation

Pancreatic cancer is the 12th most common cancer globally, and the fourth most fatal, with a mortality rate of 10.9 deaths per 100,000 people per year. The poor prognosis of pancreatic cancer patients has highlighted a significant need for new and improved approaches to treatment, which is not being met by the current market.

A highly active pancreatic cancer pipeline contains an array of products with varying molecule types and mechanisms of action, which provides a striking contrast to the current, chemotherapy dominated, market. Within the pipeline, there are 185 products that act on a first-in-class molecular target, representing 52% of the total pancreatic cancer pipeline products that have a disclosed molecular target. A drastically different pipeline and market composition implies that the approach to pancreatic cancer treatment is changing and first-in-class innovation is playing a significant role in this.

Scope

Gemcitabine based regimens continue to dominate the market, which has seen few new entrants over the past decade. The continued reliance on generic chemotherapies is one reason why the prognosis has shown little improvement.

What survival benefits do current therapies provide?

What are the current unmet needs that the pipeline needs to address?

The pipeline contains a plethora of molecule types and molecular targets not present on the market, including a large focus on therapies targeting common oncogenic pathways and signaling intermediates such as PI3K/Akt.

What impact will the emergence of biologics have on the pancreatic cancer landscape?

Will pipeline diversity translate to clinically and commercially successful therapies?

How will the rise of novel molecular target categories, such as signal transduction, impact future treatment options?

52% of pipeline products act on a first-in-class target, which is higher than the oncology and industry averages.

Do first-in-class products show strong progression into the later stages?

Why is the greatest number of first-in-class products seen in signal transduction?

Numerous early-stage, first-in-class products have high promise, often supported by preclinical evidence.

How well are first-in-class targets, such as Akt2, aligned to known disease causing pathways?

Does scientific literature provide significant rationale for therapies acting on early-stage promising, first-in-class targets?

What does preclinical data on Akt inhibition suggest about its potential as a target in pancreatic cancer?

Deals for first-in-class products typically take place in earlier stages than non-first-in-class counterparts, with 79% of first-in-class licensing deals occurring in Phase I or earlier.

To what extent does first-in-class status influence deal value?

Can biologics command a greater deal value than other molecule types?

Reasons To Buy

This report will allow you to

Understand the current clinical and commercial landscape. This includes a comprehensive study of disease pathogenesis, diagnosis, prognosis and the available treatment options available at each stage of diagnosis.

Visualize the composition of the pancreatic cancer market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the current market.

Analyze the pancreatic cancer pipeline, and stratify by stage of development, molecule type and molecular target. There are promising signs in the pipeline that the industry is seeking novel approaches the treating pancreatic cancer.

Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, first-in-class products have been assessed and ranked according to clinical potential.Promising targets, including MAP3K7 and P70-S6 Kinase 1 have been extensively reviewed using peer-reviewed literature and preclinical data.

Identify commercial opportunities in the pancreatic cancer deals landscape by analyzing trends in licensing and co-development deals and producing a curated list of pancreatic cancer therapies that are not yet involved in deals and may be potential investment opportunities.

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 3

1.2 List of Figures 3

2 Executive Summary 4

2.1 Large and Diverse Pipeline Contrasts the Limited Market 4

2.2 Pancreatic Cancer Shows High Levels of First-in-Class Innovation 4

2.3 High Deal Activity Reflects Dynamic Pipeline 4

3 The Case for Innovation 5

3.1 Growing Opportunities for Biologic Products 6

3.2 Diversification of Molecular Targets 6

3.3 Innovative First-in-Class Product Developments Remain Attractive 6

3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 7

3.5 Sustained Innovation 7

3.6 GBI Research Report Guidance 8

4 Clinical and Commercial Landscape 9

4.1 Disease Overview 9

4.2 Disease Symptoms 9

4.3 Epidemiology 9

4.4 Etiology 10

4.4.1 Risk Factors 10

4.4.2 Medical Conditions Leading to Pancreatic Cancer 10

4.4.3 Genetic Conditions Leading to Pancreatic Cancer 10

4.4.4 Conclusion 11

4.5 Pathophysiology 11

4.5.1 Frequently Dysregulated Pathways 11

4.5.2 Oncogenes 12

4.5.3 Tumor Suppressor Genes 13

4.6 Diagnosis 13

4.7 Prognosis 14

4.8 Treatment Options 14

4.8.1 Surgery 14

4.8.2 Radiation therapy 14

4.8.3 Chemotherapy 15

4.9 Chemotherapeutic Treatment Algorithm 16

4.9.1 Adjuvant Chemotherapy in Operable Early-Stage Disease 16

4.9.2 First-Line Treatment of Inoperable Advanced Disease 18

4.9.3 Second-Line Therapy in Inoperable Advanced Disease 25

4.10 Overview of Marketed Products in Pancreatic Cancer 26

4.10.1 Molecule Type and Target Analysis 26

4.10.2 Innovative Products in the Pancreatic Cancer Market 27

4.10.3 Unmet Needs 28

5 Assessment of Pipeline Product Innovation 29

5.1 Pancreatic Cancer Pipeline by Molecule Type, Phase and Therapeutic Target 29

5.2 Comparative Distribution of Programs between the Pancreatic Cancer Market and Pipeline by Therapeutic Target Family 34

5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets 35

6 Signaling Network, Disease Causation and Innovation Alignment 41

6.1 The Complexity of Signaling Networks in Oncology 41

6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 42

6.3 First-in-Class Target Matrix Assessment 45

7 First-in-Class Target Evaluation 50

7.1 Pipeline Programs Targeting HER3 50

7.2 Pipeline Programs Targeting Akt2 and Akt3 52

7.3 Pipeline Programs Targeting P70-S6 Kinase 1 55

7.4 Pipeline Programs Targeting Prostaglandin E2 Receptor EP4 Subtype 56

7.5 Pipeline Programs Targeting Ghrelin Receptor 58

7.6 Pipeline Programs Targeting Neurotensin Receptor 1 60

7.7 Pipeline Programs Targeting CD40 61

7.8 Pipeline Programs Targeting High-Affinity Nerve Growth Factor Receptor 62

7.9 Pipeline Programs Targeting Protein Kinase C Alpha 64

7.10 Pipeline Programs Targeting MAP3K7 66

7.11 Conclusion 68

8 Deals and Strategic Consolidations 69

8.1 Industry-Wide First-in-Class Deals 69

8.2 Licensing Deals 70

8.2.1 Licensing Deals by Molecule Type 74

8.2.2 Licensing Deals by Molecular Target 75

8.3 Co-development Deals 76

8.3.1 Co-development Deals by Molecule Type 78

8.3.2 Co-development Deals by Molecular Target 79

8.4 First-in-Class Programs Not Involved in Licensing or Co-Development Deals 80

9 Appendix 84

9.1 References 84

9.2 Abbreviations 87

9.3 Contact Us 88

9.4 Disclaimer 88

1.1 List of Tables

Table 1: Tumor Node Metastasis Classification 13

Table 2: Pancreatic Cancer Therapeutics, ECOG Performance Status Scores and Description 15

Table 3: Pancreatic Cancer Therapeutics, Common Endpoints in Oncology Clinical Trials and their Description 16

Table 4: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine Monotherapy 16

Table 5: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine Monotherapy 17

Table 6: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine in Combination with Eloxatin 20

Table 7: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine in Combination with Cisplatin 21

Table 8: Pancreatic Cancer Therapeutics, Typical Dosing of Teysuno based on Body Surface Area of Patient 23

Table 9: Pancreatic Cancer Therapeutics, Adverse Events Associated with Gemcitabine Monotherapy, Teysuno Monotherapy, and with their Combination 24

Table 10: Pancreatic Cancer Therapeutics, Improvements in Overall Survival with Gemcitabine Drug Combinations 25

1.2 List of Figures

Figure 1: Innovation Trends in Product Approvals 5

Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Product Post Marketing Approval 7

Figure 3: Genetically Altered Signaling Pathways in Pancreatic Cancer 12

Figure 4: Overview of Marketed Products in Pancreatic Cancer 27

Figure 5: Overview of Pipeline Products 30

Figure 6: Breakdown of Pipeline Molecular Targets 33

Figure 7: Pipeline Products by Stage and Molecular Target 34

Figure 8: Molecular Target Family Comparison, Pipeline and Marketed Products 34

Figure 9: Molecular Target Family Comparison, Pipeline First-in-Class and Established Molecular Targets 36

Figure 10: Percentage of First-in-Class Products within Pancreatic Cancer Pipeline Molecular Target Families 37

Figure 11: Percentage of First-in-Class Products within Pancreatic Cancer Pipeline Stages of Development 37

Figure 12: List of First-in-Class Products (Part 1) 38

Figure 13: List of First-in-Class Products (Part 2) 39

Figure 14: List of First-in-Class Products (Part 3) 40

Figure 15: Pancreatic Cancer Signaling Network Assessment (Part 1) 43

Figure 16: Pancreatic Cancer Signaling Network Assessment (Part 2) 44

Figure 17: Pancreatic Cancer Target Matrix Assessment (Part 1) 46

Figure 18: Pancreatic Cancer Target Matrix Assessment (Part 2) 47

Figure 19: Pancreatic Cancer Target Matrix Assessment (Part 3) 48

Figure 20: Pancreatic Cancer Target Matrix Assessment (Part 4) 49

Figure 21: Data and Evidence for ErbB3 as a Therapeutic Target 51

Figure 22: Pipeline Products Targeting ErbB3 52

Figure 23: Data and Evidence for Akt as a Therapeutic Target 54

Figure 24: Pipeline Products Targeting Akt2 and Akt3 55

Figure 25: Data and Evidence for P70-S6 Kinase 1 as a Therapeutic Target 56

Figure 26: Pipeline Products Targeting P70-S6 Kinase 1 56

Figure 27: Data and Evidence for PGE2 as a Therapeutic Target 57

Figure 28: Pipeline Products Targeting PGE2 58

Figure 29: Data and Evidence for Ghrelin as a Therapeutic Target 59

Figure 30: Pipeline Products Targeting Ghrelin Receptor 60

Figure 31: Data and Evidence for NTR1 as a Therapeutic Target 61

Figure 32: Pipeline Products Targeting NTR1 61

Figure 33: Pipeline Products Targeting CD40 62

Figure 34: Data and Evidence for High-Affinity NGF Receptor as a Therapeutic Target 63

Figure 35: Pipeline Products Targeting High-Affinity NGF Receptor 63

Figure 36: Data and Evidence for PKC Alpha as a Therapeutic Target 65

Figure 37: Pipeline Products Targeting PKC Alpha 65

Figure 38: Data and Evidence for MAP3K7 as a Therapeutic Target 67

Figure 39: Pipeline Products Targeting MAP3K7 68

Figure 40: Industry-Wide Deals by Stage of Development, 2006-2014 69

Figure 41: Industry Licensing Deal Values by Stage of Development, 2006-2014 70

Figure 42: Pancreatic Cancer Licensing Deal Values 71

Figure 43: Pancreatic Cancer Licensing Deals by Year 72

Figure 44: Pancreatic Cancer Licensing Deals by Phase 73

Figure 45: Pancreatic Cancer Licensing Deals by Global Distribution 74

Figure 46: Pancreatic Cancer Licensing Deals by Molecule Type 75

Figure 47: Pancreatic Cancer Licensing Deal Value by Molecular Target Category 75

Figure 48: Pancreatic Cancer Co-development Deal Values 76

Figure 49: Pancreatic Cancer Co-development Deals by Year 76

Figure 50: Pancreatic Cancer Co-development Deals by Phase 77

Figure 51: Pancreatic Cancer Co-development Deals by Global Distribution 78

Figure 52: Pancreatic Cancer Co-development Deals by Molecule Type 79

Figure 53: Pancreatic Cancer Co-development Deal Value by Molecular Target 79

Figure 54: Pancreatic Cancer First-in-Class Therapies not Involved in Deals (Part 1) 81

Figure 55: Pancreatic Cancer First-in-Class Therapies not Involved in Deals (Part 2) 82

Figure 56: Pancreatic Cancer First-in-Class Therapies not Involved in Deals (Part 3) 83

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